| CTRI Number |
CTRI/2025/11/096937 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How different hip scan classifications relate to hip function in people with osteonecrosis of femoral head |
|
Scientific Title of Study
|
Association between various radiological classifications and hip function scores in osteonecrosis of femoral head |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tazeem Ali |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Orthopaedics Lok Nayak Hospital Central Delhi 110002
Central
DELHI
110002
India |
| Phone |
9213630677 |
| Fax |
|
| Email |
tazeem1002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Arora |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 608 Department of Orthopaedics Lok Nayak Hospital New Delhi
Central
DELHI
110002
India |
| Phone |
9868329389 |
| Fax |
|
| Email |
sumitaroraortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Arora |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 608 Department of Orthopaedics Lok Nayak Hospital New Delhi
Central
DELHI
110002
India |
| Phone |
9868329389 |
| Fax |
|
| Email |
sumitaroraortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2 Bahadur Shah Zafar Marg New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tazeem Ali |
Lok Nayak Hospital |
Department of Orthopaedics Jawaharlal Nehru Marg
Maulana Azad Medical College Campus Delhi Gate
Central
DELHI |
09213630677
tazeem1002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M16||Osteoarthritis of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All stages of osteonecrosis of femoral head as per Modified Ficats staging |
|
| ExclusionCriteria |
| Details |
Traumatic osteonecrosis of femoral head
Patients who have undergone any previous hip surgery for osteonecrosis
Patients with contraindications to MRI internal cardiac pacemaker implantable cardiac defibrillator cochlear and ocular implants aneurysm and hemostatic clips MR incompatible metallic implants
Pregnant women
Patients with cognitive impairment and inability to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between different radiological classifications and different hip function scores |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Association between different radiological classifications.
2 Correlation between different hip function scores.
3 Correlation of BMI with various hip function scores.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The disruption of the proximal femur’s blood supply results in osteonecrosis of the femoral head (ONFH). This lack of blood flow then results in death of osteocyte (osteonecrosis) that can be caused by either traumatic events or can result from non-traumatic events. The primary aim of the study is to determine the association between radiological classification and hip function scores in patients diagnosed with non-traumatic osteonecrosis of femoral head. |